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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE

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ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE Back to Search Results
Model Number SGC0701
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem Perforation (2001)
Event Date 11/18/2021
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional two devices referenced are filed under separate medwatch report numbers.
 
Event Description
This is filed to report atrial perforation. It was reported this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with a grade of 4. It was noted the patient had a floppy septum and imaging was very challenging. The steerable guide catheter (sgc) and an ntw clip delivery system (cds) were inserted. However, due to the floppy septum, the sgc was difficult position. Also, due to the poor imaging, it was difficult to visualize the sgc and cds. Although imaging was very poor, the physician decided to attempt to steer down into the left ventricle (lv). It was noted a lot of tension was put on the device due an excessive amount of steering. When attempting to release some of that tension, it was observed the clip moved in an unintended direction. The cds was attempted to be pulled back into the left atrium (la), but the clip became caught in the chordae and the commissure, resulting in a clinically significant delay in the procedure. Troubleshooting was performed and the clip was able to be retracted into the la. However, a chordal rupture occurred. The physician decided to remove the cds and replace it with another ntw. The clip was deployed on the mitral valve without issues. To further reduce mr, an nt clip was inserted and attempted to be placed laterally of the first clip. However, while grasping, the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda). The nt clip was then repositioned to stabilize the slda. Mr was reduced to a grade of 2. Once the cds and sgc were removed, a left to right shunt was observed. However, no treatment was performed. No additional information was provided.
 
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Brand NameG4 STEERABLE GUIDING CATHETER
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12953148
MDR Text Key281858670
Report Number2024168-2021-11182
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSGC0701
Device Catalogue NumberSGC0701
Device Lot Number10520R215
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2021 Patient Sequence Number: 1
Treatment
CLIP DELIVERY SYSTEM
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